SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE)

TherOx

Status

Enrolling

Conditions

AMI

STEMI - ST Elevation Myocardial Infarction

Treatments

Other: No intervention

Study type

Observational

Funder types

Industry

Identifiers

NCT06438315

EDC-5731

Details and patient eligibility

About

The SuperSaturated Oxygen Comprehensive Observational Registry (SSCORE) registry, a prospectively designed observational study, aims to evaluate the clinical utility and effectiveness of SuperSaturated Oxygen (SSO2) Therapy versus percutaneous coronary intervention (PCI) alone among patients with anterior acute myocardial infarction (AMI) in routine clinical practice. The goal is to collect real-world data from patients treated with SSO2 Therapy to determine its impact on the overall heart failure (HF) burden on patients and healthcare systems compared with usual care for treatment of patients with AMI. The SSCORE Registry will generate effectiveness and healthcare resource utilization data that will be used in cost-effectiveness analysis modeling.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Subjects screened for either the Prospective Control Cohort or the SSO2 Treated (On-Label or All Others) Cohorts must meet ALL the following baseline criteria:

Men or women aged 18 years or older
Presentation with AMI and successful revascularization of the infarct-related artery with PCI
The subject or their legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Institutional Review Board (IRB)

Treatment with SSO2 Therapy will be up to the physician's discretion and the decision will be made prior to enrollment in the study. Any subject that is treated with SSO2 Therapy and meets the baseline criteria should be invited to participate in the study.

Subjects who are in the Prospective Control Cohort as well as subjects enrolled in the SSO2 Treated On-Label Cohort must meet these additional criteria:

The primary culprit lesion must be in the left anterior descending (LAD) coronary tree
Successful primary PCI within 6 hours of symptom onset, as documented by <50% diameter residual angiographic stenosis and Thrombolysis in Myocardial Infarction (TIMI) Grades 2 or 3 flow in the target vessel
No major complications such as perforation, serious bleeding, or cardiogenic shock
Not pregnant or nursing

Exclusion Criteria

Subjects will be excluded if they meet any of the following criteria:
Life expectancy of less than 2 years
No access to medical records from either the index hospitalization or subsequent outpatient visits
Currently participating in an investigational drug or device trial